86R19298 KKR-F
By: Parker H.B. No. 805
Substitute the following for H.B. No. 805:
By: Sheffield C.S.H.B. No. 805
A BILL TO BE ENTITLED
AN ACT
relating to access to certain investigational drugs, biological
products, and devices that are in clinical trials by patients with
severe chronic diseases.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. (a) This Act shall be known as the "Medical
Freedom Act."
(b) The legislature finds that:
(1) the Right To Try Act, as added by Chapter 502 (H.B.
21), Acts of the 84th Legislature, Regular Session, 2015, has had
tremendous success in saving the lives of many patients with a
terminal illness;
(2) the process for approving the use of
investigational drugs, biological products, and devices by
patients without a terminal illness who need access to the drugs,
products, or devices continues to take many years in the United
States;
(3) patients who are battling a severe chronic disease
that is debilitating or causes severe pain do not have the luxury of
waiting until an investigational drug, biological product, or
device receives final approval from the United States Food and Drug
Administration;
(4) the standards of the United States Food and Drug
Administration for the use of investigational drugs, biological
products, and devices may deny the benefits of potentially
life-altering treatment to patients with a severe chronic disease;
(5) patients with a severe chronic disease have a
fundamental right to attempt to pursue the preservation of their
state of life by accessing available investigational drugs,
biological products, and devices;
(6) the use of available investigational drugs,
biological products, and devices is a decision that should be made
by a patient with a severe chronic disease in consultation with the
patient's physician and is not a decision to be made by the
government; and
(7) the decision to use an investigational drug,
biological product, or device should be made with full awareness of
the potential risks, benefits, and consequences to a patient with a
severe chronic disease and the patient's family.
(c) It is the intent of the legislature to allow patients
with a severe chronic disease to use potentially life-altering
investigational drugs, biological products, and devices.
SECTION 2. Subtitle C, Title 6, Health and Safety Code, is
amended by adding Chapter 490 to read as follows:
CHAPTER 490. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS
WITH SEVERE CHRONIC DISEASES
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 490.001. DEFINITIONS. In this chapter:
(1) "Commissioner" means the commissioner of state
health services.
(2) "Executive commissioner" means the executive
commissioner of the Health and Human Services Commission.
(3) "Investigational drug, biological product, or
device" means a drug, biological product, or device that has
successfully completed phase one of a clinical trial but has not yet
been approved for general use by the United States Food and Drug
Administration or its international equivalent and remains under
investigation in the clinical trial. The term does not include
low-THC cannabis, as defined by Section 169.001, Occupations Code,
or a product containing marihuana, as defined by Section 481.002,
regardless of whether the cannabis or product has successfully
completed phase one of a clinical trial.
(4) "Severe chronic disease" means a condition,
injury, or illness that:
(A) may be treated;
(B) may not be cured or eliminated; and
(C) entails significant functional impairment or
severe pain.
Sec. 490.002. DESIGNATION OF SEVERE CHRONIC DISEASES. The
commissioner shall designate the medical conditions considered to
be severe chronic diseases under this chapter.
Sec. 490.003. RULES. The executive commissioner shall
adopt rules necessary to administer this chapter.
SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
PRODUCTS, AND DEVICES FOR PATIENTS WITH SEVERE CHRONIC DISEASES
Sec. 490.051. PATIENT ELIGIBILITY. A patient is eligible
to access and use an investigational drug, biological product, or
device under this chapter if:
(1) the patient has a severe chronic disease
designated by the commissioner under Section 490.002 and attested
to by the patient's treating physician;
(2) the use of the investigational drug, biological
product, or device is consistent with this chapter and rules
adopted under this chapter; and
(3) the patient's physician:
(A) in consultation with the patient, considers
all other treatment options currently approved by the United States
Food and Drug Administration and determines those treatment options
are unavailable or unlikely to provide relief for the significant
impairment or severe pain associated with the patient's severe
chronic disease; and
(B) recommends or prescribes in writing the
patient's use of a specific class of investigational drug,
biological product, or device.
Sec. 490.052. INFORMED CONSENT. (a) Before receiving an
investigational drug, biological product, or device, an eligible
patient must sign a written informed consent. If the patient is a
minor or lacks the mental capacity to provide informed consent, a
parent, guardian, or conservator may provide informed consent on
the patient's behalf.
(b) The commissioner may prescribe a form for the informed
consent required under this section.
Sec. 490.053. NO CAUSE OF ACTION CREATED. This chapter does
not create a private or state cause of action against a manufacturer
of an investigational drug, biological product, or device or
against any other person or entity involved in the care of an
eligible patient using the investigational drug, biological
product, or device for any harm to the eligible patient resulting
from the investigational drug, biological product, or device.
Sec. 490.054. STATE MAY NOT INTERFERE WITH ACCESS TO
INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. An official,
employee, or agent of this state may not block or attempt to block
an eligible patient's access to an investigational drug, biological
product, or device under this chapter unless the drug, biological
product, or device is considered adulterated or misbranded under
Chapter 431. For purposes of this section, a governmental entity
may not consider the drug, biological product, or device to be
adulterated or misbranded solely on the basis that the United
States Food and Drug Administration has not approved the drug,
biological product, or device.
SUBCHAPTER C. HEALTH INSURANCE
Sec. 490.101. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
TRIAL ENROLLEES. This chapter does not affect the coverage of
enrollees in clinical trials under Chapter 1379, Insurance Code.
SUBCHAPTER D. PHYSICIANS
Sec. 490.151. ACTION AGAINST PHYSICIAN'S LICENSE
PROHIBITED. Notwithstanding any other law, the Texas Medical Board
may not revoke, fail to renew, suspend, or take any action against
a physician's license under Subchapter B, Chapter 164, Occupations
Code, based solely on the physician's recommendations to an
eligible patient regarding access to or treatment with an
investigational drug, biological product, or device, provided that
the recommendations meet the medical standard of care and the
requirements of this chapter.
SECTION 3. (a) As soon as practicable after the effective
date of this Act, the commissioner of state health services shall
designate the medical conditions considered to be severe chronic
diseases as required by Section 490.002, Health and Safety Code, as
added by this Act.
(b) As soon as practicable after the effective date of this
Act, the executive commissioner of the Health and Human Services
Commission shall adopt the rules required by Section 490.003,
Health and Safety Code, as added by this Act. The executive
commissioner may adopt initial rules in the manner provided by law
for emergency rules.
SECTION 4. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2019.